Growth and Enteral Tolerance of Plant-Based Enteral Formulas: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Weight-for-length z-score
研究概览
简要总结
The purpose of this prospective study is to evaluate the growth and enteral tolerance of two pea protein-based formulas from Kate Farms in children aged 12 to 17 months who are expected to meet most of their nutritional needs through formula. It is hypothesized that the Pediatric Standard 1.2 and Pediatric Peptide 1.0 formulas will support healthy growth in children between 1 and 2 years of age. The study will assess the impact of these formulas on growth, tolerance, body composition, micronutrient levels, and gut microbiome health in tube-fed children. Formula will be provided for 24 weeks.
详细描述
This is a prospective cohort study. Forty children ages 12-17 months who rely on formula for at least 80% of their nutritional needs (by mouth of tube feeding) are expected to continue this dependence for the next 6 months will be recruited. Children will be recruited from the Feeding Program, GI clinic and Complex Care clinic at Nationwide Children's Hospital in Columbus, Ohio. The study will be introduced to the patient by the provider during a routine clinic visit. Parent consent will be obtained from one of the research investigators during the clinic visit.
The objectives are to study the effect of these formulas on the functions of the body (AND NOT to evaluate its role in any disease state) in the form of growth and nutrition status.
- To sustain/improve to a weight-for-length z-score of between -1 and 0 up through 24 weeks, in children who are predominantly receiving nutrition via formula (either orally or via tube feeding)
Secondary study objectives:
- To sustain other anthropometric measurements
- To assess tolerance
- To assess changes in body composition and gut microbiome
- To assess changes in key micronutrients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 17 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, male or female, aged 12 through 17 months (for premature infants, we will use corrected age)
- •Children with a weight-for-length z score between ≥ -1.5 at enrolment
- •Children obtaining via formula feeding ≥ 80% of their total energy intake at enrolment and expected to continue to require such formula intake for the next 24 weeks
- •Children from families who are willing and able to comply with the requirements of the protocol
- •Written informed consent from the parent or legal guardian
- •Parent/caregiver or legal guardian must be able to read, write, and understand English
排除标准
- •Children with known or suspected complex gastrointestinal anomalies or dysfunction, hepatic or renal dysfunction, or inherited metabolic disorders, suspected or diagnosed conditions associated with malabsorption (e.g. cystic fibrosis) (Note: For hepatic dysfunction, a conjugated bilirubin >2.0 mg/dL and for renal dysfunction child should not meet any of the Pediatric Risk, Injury, Failure, Loss, End Stage Renal Disease (pRIFLE) criteria for renal disease (estimated creatinine clearance decreased by 25% by the Schwartz formula or urine output <0.5 mL/kg per hour over the previous 8 or more hours) or has chronic medical renal disease. We will not obtain labs to exclude children. If children are noted to have liver disease or renal disease in their chart, we will look at their labs to ensure that they do not meet exclusion criteria).
- •Children with tracheostomy and/or inspired oxygen via nasal cannula or children receiving diuretics.
- •Children with known or suspected genetic and/or metabolic inborn errors of metabolism conditions known to interfere with growth or body dysmorphology that can interfere with obtaining standard anthropometric measurements (weight, length, head circumference, and arm circumference)
- •At study entry, children expected to consume on average more than 20% of their energy intake from non-formula sources of nutrition: solids, expressed breast milk and /or parenteral nutrition.
- •Child requiring or expected to have an energy requirement < 80 kcal/kg per day - Breastfeeding child (who is feeding at the breast > 2 times per day)
- •Child likely to undergo major surgery during the duration of the study
- •Child with a nasogastric tube that is unlikely to get a gastrostomy tube during the duration of the study
- •Principal Investigator's uncertainty about the willingness or ability of the parent/caregiver to comply with the protocol requirements
- •Children whose parent is younger than the legal age of consent
- •Children with known allergy to pea protein or soy or peanuts.
- •Children with a parent or a sibling with a known allergy to pea protein or soy or peanuts.
研究组 & 干预措施
Formula
The study intervention will be 2 pea protein-based formulas Kate Farms Pediatric Standard formula 1.2 (KF-PS) and Kate Farms Standard Pediatric Peptide Formula 1.0 (KF-PP).
干预措施: Kate Farms Standard 1.2 or Peptide 1.0 (Dietary Supplement)
结局指标
主要结局
Weight-for-length z-score
时间窗: 24 weeks
To sustain/improve to a weight-for-length z-score of between -1 and 0 up through 24 weeks, in children who are predominantly receiving nutrition via formula (either orally or via tube feeding)
次要结局
- Length velocity(24 weeks)
- Tolerance - Stool consistency(24 weeks)
- Gastrointestinal (GI) and gastroesophageal (GER) reflux symptoms(24 weeks)
- Body Composition(24 weeks)
- Head circumference-for-age(24 weeks)
- Weight-for-age(24 weeks)
- Length-for-age(24 weeks)
- Mid upper arm circumference (MUAC)-for-age(24 weeks)
- Weight velocity(24 weeks)
- Tolerance - Spit up/vomiting(24 weeks)
- Tolerance - Stool(24 weeks)
- Gut Microbiome(24 weeks)
- Micronutrient analysis(24 weeks)